• Clinical Trial Associate

    Job ID
    2018-1163
    Category
    Clinical Operations
    Job Location
    US-MA-Cambridge
  • Company Summary

    Jounce Therapeutics, Inc. is a clinical stage immunotherapy company dedicated to transforming the treatment of cancer by developing therapies that enable the immune system to attack tumors and provide long‑lasting benefits to patients. Through the use of its Translational Science Platform, Jounce first focuses on specific cell types within tumors to prioritize targets, and then identifies related biomarkers designed to match the right therapy to the right patient. Jounce’s lead product candidate, JTX-2011, is a monoclonal antibody that binds to and activates ICOS and is currently in the Phase 2 portion of the Phase 1/2 ICONIC trial. For more information, please visit www.jouncetx.com.

    Role / Responsibilities

    The successful candidate will assist with daily clinical trial execution activities and assist in the coordination of documentation associated with the conduct of investigational clinical studies in accordance with Food and Drug Administration (FDA) Regulations, Good Clinical Practice (GCP), and company standard operating policies and procedures.

     

    Responsibilities:

     

    • Responsible for study laboratory sample management, including tracking and vendor management support
    • Collect trial information and disseminate it to the internal project team, the CRO, and other stakeholders
    • Schedule and coordinate study meetings, materials and agendas; recording and disseminating decisions and actions
    • Responsible for quality control of the eTMF including maintenance and oversight
    • Coordinate and manage version control of clinical documents.
    • Prepare distribution of copies of finalized protocol and study documents. Assemble investigator and pharmacy manuals
    • Assist in responding to Data Correction Forms (DCFs) and track DCF follow-up and completion activities.
    • Assist in the coordination and tracking of clinical supply shipments, including review and approval of Regulatory Documentation Packages
    • Assist in the creation and updating of standardized clinical trial tools, processes, and SOPs
    • Organize and maintain tracking systems and tools to support the conduct of a clinical study from start-up to close-out

    Qualifications

    • BS/BA degree or equivalent and at least year experience in clinical operations in Sponsor company with 1+ years strongly preferred
    • Knowledge of drug development, clinical operation processes and documentation including study start up procedures, maintenance phase, and study close out procedures
    • Knowledge and implementation of the processes involved in clinical studies following Good Clinical Practice (GCP) and the Code of Federal Regulations is required
    • Experience with eTMF; ability to directly apply essential document knowledge to file documents
    • Strong communication, organizational and interpersonal/team skills
    • Proficient in MS Excel, Word and PowerPoint.  Knowledge of MS project preferred.
    • Established ability to prioritize and manage multiple tasks simultaneously, demonstrated ability to identify and resolve issues, and effectively manage timelines
    • Participate in inter-departmental workgroups to create or enhance processes
    • Strong customer service orientation
    • Strong attention to quality/detail

    Statement

    Jounce Therapeutics is an equal opportunity employer and does not discriminate in it’s employment decisions on the basis of race, color, national origin, age, physical or mental disability, marital status, religion, creed, sex, or political beliefs.  We offer a competitive salary and benefits package. All applicants should be legally entitled to work for any employer in the U.S.

     

     

    To apply, please visit https://careers-jouncetx.icims.com/.

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